3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-11-01 to 1984-11-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Two rats used per group. Environmental conditions not specified. Type of coverage and study duration not specified. No data on post-mortem examinations, clinical signs or body weights.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Two rats used per group. Environmental conditions not specified. Type of coverage and study duration not specified. No data on post-mortem examinations, clinical signs or body weights.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

EC Number:

219-588-7

EC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Cas Number:

2469-55-8

Molecular formula:

C10H28N2OSi2

IUPAC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Indiana
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adults
- Weight at study initiation: 2582 - 2786 g at study initiation
- Fasting period before study: not specified
- Housing: Individual hanging wire-mesh cages
- Diet (e.g. ad libitum): Purina Cerified Rabbit Chow #5322
- Water (e.g. ad libitum): not specified
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dermal application, area not specified
- % coverage: not specified
- Type of wrap if used: not specified

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: 24-hour application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose volume not specified
- Concentration (if solution): the test material was applied undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

one male and one female per group

Control animals:

not required

Details on study design:

- Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: not specified
- Other examinations performed: not specified

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study period.

Clinical signs:

None reported.

Body weight:

None reported.

Gross pathology:

None reported.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study conducted according to a protocol similar to OECD 402 and in compliance with GLP, the LD50 value reported for 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine was >= 2000 mg/kg bw.